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CDER 2008 Meeting Documents


Anesthetic and Life Support Drugs Advisory Committee
Executive Secretary: Kalyani Bhatt, B.Sc., M.S., (HFD-21), (301) 827-7001

November 13-14, 2008 (Joint Meeting with the Drug Safety and Risk Management) (Meeting ID: 2008-4395)

  • Notice of Meeting (htm)
  • Final Agenda for November 13, 2008 Meeting (pdf)
  • Agenda for November 13, 2008 Meeting (pdf)
  • Final Agenda for November 14, 2008 Meeting (pdf)
  • Draft Agenda for November 14, 2008 Meeting (pdf)
  • Draft Meeting Roster for November 13, 2008 Meeting (pdf)
  • Draft Meeting Roster for November 14, 2008 Meeting (pdf)
  • Briefing Information for November 13, 2008 Meeting (htm)
  • Briefing Information for November 14, 2008 Meeting (htm)
  • Slides for November 13, 2008 Meeting (htm)
  • Slides for November 14, 2008 Meeting (htm)
  • Transcript for November 14, 2008 Meeting: Part1 (pdf), Part2 (pdf)
  • Final Minutes for November 13, 2009 Meeting (pdf), Revised Minutes for November 13, 2009 (pdf) (5/29/09)
  • Final Minutes for November 14, 2009 Meeting (pdf), Revised Minutes for November 13, 2009 (pdf) (5/29/09)

May 7, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Final Agenda for May 7, 2008 Meeting (pdf)
  • Briefing Information for May 7, 2008 Meeting (htm)
  • Draft Questions for May 7, 2008 Meeting (pdf)
  • Slides (htm)
  • Minutes (pdf)
  • Transcript: Index (pdf), Part1 (pdf), Part2 (pdf), Part3 (pdf)

May 5 and 6, 2008 (Joint Meeting with the Drug Safety & Risk Management Advisory Committee)

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Waivers for Conflicts of Interest (htm)
  • Draft Agenda for May 5, 2008 Meeting (pdf)
  • Draft Agenda for May 6, 2008 Meeting (pdf)
  • Briefing Information for May 5, 2008 Meeting (html)
  • Briefing Information for May 6, 2008 Meeting (htm)
  • Draft Questions for May 5, 2008 Meeting (pdf)
  • Draft Questions for May 6, 2008 Meeting (pdf)
  • Slides for May 5, 2008 Meeting (htm)
  • Slides for May 6, 2008 Meeting (htm)
  • Minutes for May 5, 2008 Meeting (pdf)
  • Minutes for May 6, 2008 Meeting (pdf)
  • Transcript for May 5, 2008 Meeting: Index (pdf), Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)
  • Transcript for May 6, 2008 Meeting: Index (pdf), Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)

March 11, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Waivers for Conflicts of Interest for March 4-5, 2008 Meeting (htm)
  • Final Agenda (pdf)
  • Draft Agenda (pdf)
  • Committee Roster (pdf)
  • Briefing Information (htm)
  • Final Questions (pdf)
  • Slides (htm)
  • Transcript: Part 1 (pdf), Part 2 (pdf), Part 3 (pdf)
  • Final Minutes (pdf)

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Anti-Infective Drugs Advisory Committee
Executive Secretary: Janie Kim, Pharm.D., (HFD-21), (301) 827-7001

December 3, 2008 (Meeting ID: 2008-4388)

November 18, 19, and 20, 2008

  • Notice of Meeting (htm) (Meeting ID: 20008-4394)
  • Draft Agenda for November 18, 2008 Meeting (pdf)
  • Morning Draft Agenda for November 19, 2008 Meeting (pdf)
  • Afternoon Draft Agenda for November 19, 2008 Meeting (pdf)
  • Draft Agenda for November 120, 2008 Meeting (pdf)
  • Meeting Roster for for November 18, 2008 Meeting (pdf)
  • Morning Draft Meeting Roster for November 19, 2008 Meeting (pdf)
  • Afternoon Draft Meeting Roster for November 19, 2008 Meeting (pdf)
  • Draft Meeting Roster for November 20, 2008 Meeting (pdf)
  • Briefing Information for November 18, 2008 Meeting (htm) (Updated 11/14/08)
  • Briefing Information for November 19, 2008 Meeting (htm)
  • Briefing Information for November 20, 2008 Meeting (htm)
  • Posted Final Minutes for November 18, 2008 Meeting (pdf)
  • Final Minutes for Morning Session on November 19, 2008 Meeting (pdf)
  • Final Minutes for Afternoon Session on November 19, 2008 Meeting (pdf)
  • Final Minutes for November 20, 2008 Meeting (pdf)
  • Slides for November 18, 2008 Meeting (htm)
  • Slides for November 19, 2008 Meeting (htm)
  • Slides for November 20, 2008 Meeting (htm)
  • Transcript for November 18, 2008 Meeting: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)
  • Transcript for November 19, 2008 Meeting: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)
  • Transcript for November 20, 2008 Meeting: Part1 (pdf), Part2 (pdf)

July 16, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • No Waivers for Conflicts of Interest
  • Draft Agenda (pdf)
  • Rosters: AIDAC Committee (pdf), Meeting (pdf)
  • Briefing Information (htm)
  • Transcript: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)
  • Final Minutes (pdf)
  • Slides (htm)

April 1 and 2, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Final Agenda for April 1 and 2, 2008 Meeting (pdf)
  • Draft Agenda [pdf]
  • Final Roster for April 1 and 2, 2008 Meetings: Committee (pdf), Meeting (pdf)
  • Rosters: Attendee (pdf), Committee (pdf)
  • Briefing Information (htm)
  • Final Questions for April 1 and 2, 2008 Meeting (pdf)
  • Draft Questions (pdf)
  • Slides for April 1, 2008 Meeting (htm)
  • Slides for April 2, 2008 Meeting (htm)
  • Transcripts for April 1, 2008 Meeting: Index (pdf), Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf), Part5 (pdf)
  • Transcripts for April 2, 2008 Meeting: Index (pdf), Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf), Part5 (pdf)
  • Final Minutes for April 1 and 2, 2009 Meeting (pdf)

February 27, 2008 : CANCELLED

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Antiviral Drugs Advisory Committee
Executive Secretary: Paul Tran, R.Ph., HFD-21 (301) 827-7001

December 2, 2008 (Meeting ID: 2008-4402)

NOTICE: Meeting location change: Meeting moved to Hilton Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD

October 30, 2008

October 29, 2008 (Joint Meeting with the Nonprescription Drugs Advisory Committee) (Meeting ID: 2008-4385)

  • Notice of Meeting (htm)
  • Waivers for Conflicts of Interest (htm)
  • Draft Agenda (pdf)
  • Rosters: AVAC Committee (pdf), NDAC Committee (pdf), Meeting Committee (pdf)
  • Briefing Information (htm)
  • Final Questions (pdf)
  • Questions (pdf)
  • Minutes (pdf)
  • Slides (htm)
  • Transcript: Index (pdf), Part 1 (pdf)

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Arthritis Drug Advisory Committee
Executive Secretary: Niclole Vesely, Pharm. D., RPL (HFD-21), (301) 827-7001

November 24, 2008 (Meeting ID: 2008-4387)

  • Notice of Meeting (htm)
  • Final Agenda (pdf)
  • Draft Agenda (pdf)
  • Final Meeting Roster (pdf)
  • Rosters: Committee (pdf), Meeting (pdf)
  • Briefing Information (htm)
  • Final Questions (pdf)
  • Minutes (pdf)
  • Slides (htm)
  • Transcript: Part1 (pdf), Part2 (pdf), Part3 (pdf)

July 29, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Final Agenda (pdf)
  • Draft Agenda (pdf)
  • Rosters: Committee (pdf), Meeting (pdf)
  • Briefing Information (htm)
  • Slides (htm)
  • Transcript: Part1 (pdf), Part2 (pdf), Part3 (pdf)
  • Minutes (pdf)

Cardiovascular & Renal Drugs Advisory Committee
Executive Secretary: Elaine Ferguson, R.Ph., M.S., (HFD-21), (301) 827-7001

December 10, 20088 (Meeting ID: 2008-4390)

June 24, 2008

June 25, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Draft Roster for June 25, 2008 Meeting (pdf)
  • Briefing Information for June 25, 2008 Meeting (htm)
  • Transcript: Index (pdf), Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)
  • Slides (htm)
  • Minutes (pdf)

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Dermatologic and Ophthalmic Drugs Advisory Committee
Executive Secretary: LT Yvette Waples, Pharm.D., (HFD-21), (301) 827-7001

December 5, 2008 (Meeting ID: 2008-4397)

  • Notice of Meeting
  • Final Agenda (pdf)
  • Draft Agenda (pdf)
  • Rosters: Committee (pdf), Meeting (pdf)
  • Briefing Information (htm)
  • Final Questions for Morning Session (pdf)
  • Final Questions for Afternoon Session (pdf)
  • Questions (pdf)
  • Transcript for Morning Session (pdf)
  • Transcript for Afternoon Session (pdf)
  • Minutes (pdf)

June 17 and June 18, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Important Notice - Change in Meeting Location (pdf)
  • Draft Agenda for June 17, 2008 Meeting (pdf)
  • Draft Agenda for June 18, 2008 Meeting (pdf)
  • Rosters for June 17, 2008 Meeting: Committee (pdf), Meeting (pdf)
  • Rosters for June 18, 2008 Meeting: Committee (pdf), Meeting (pdf)
  • Briefing Information for June 17, 2008 Meeting (htm)
  • Briefing Information for June 18, 2008 Meeting (htm)
  • Addendum to Briefing Material for June 18, 2008 Meeting (pdf)
  • Questions for June 17, 2008 Meeting (pdf)
  • Questions for June 18, 2008 Meeting (pdf)
  • Transcripts for June 17, 2008 Meeting: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf), Part5 (pdf)
  • Transcripts for June 18, 2008 Meeting: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)
  • Minutes for June 17, 2008 Meeting (pdf)
  • Minutes for June 18, 2008 Meeting (pdf)

May 29, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Final Agenda (pdf)
  • Draft Agenda (pdf)
  • Rosters: Committee (pdf), Meeting (pdf)
  • Briefing Information (htm)
  • Final Questions (pdf)
  • Draft Questions (pdf)
  • Slides (htm)
  • Transcript (pdf)
  • Minutes (pdf)

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Drug Safety and Risk Management Advisory Committee
Executive Secretary: Elaine Ferguson, R.Ph., M.S., (HFD-21), (301) 827-7001

December 10 and 11, 2008 (Joint meeting with Pulmonary-Allergy Drugs Advisory Committee and the Pediatric Adavisory Committee) (Meeting ID: 2008- 4398)

  • Notice of Meeting (htm)
  • Waivers for Conflicts of Interest (htm)
  • Final Agenda (pdf)
  • Draft Agenda (pdf)
  • Meeting Roster (pdf)
  • Briefing Information (htm)
  • Final Questions (pdf)
  • Comments (pdf)
  • Slides for December 10, 2008 (htm)
  • Slides for December 11, 2008 (htm)
  • Final Minutes for December 10 and 11, 2008 (pdf)
  • Transcript for December 10, 2008 Meeting (pdf)
  • Transcript for December 11, 2008 Meeting (pdf)

November 13-14, 2008 (Joint Meeting with the Anesthetic and Life Support Drugs) (Meeting ID: 2008-4395)

  • Notice of Meeting (htm)
  • Final Agenda for November 13, 2008 Meeting (pdf)
  • Agenda for November 13, 2008 Meeting (pdf)
  • Final Agenda for November 14, 2008 Meeting (pdf)
  • Draft Agenda for November 14, 2008 Meeting (pdf)
  • Draft Meeting Roster for November 13, 2008 Meeting (pdf)
  • Draft Meeting Roster for November 14, 2008 Meeting (pdf)
  • Briefing Information for November 13, 2008 Meeting (htm)
  • Briefing Information for November 14, 2008 Meeting (htm)
  • Slides for November 13, 2008 Meeting (htm)
  • Slides for November 14, 2008 Meeting (htm)
  • Transcript for November 13, 2008 Meeting (pdf)
  • Transcript for November 14, 2008 Meeting: Part1 (pdf), Part2 (pdf)
  • Final Minutes for November 13, 2009 Meeting (pdf), Revised Minutes for November 13, 2009 (pdf) (5/29/09)
  • Final Minutes for November 14, 2009 Meeting (pdf), Revised Minutes for November 13, 2009 (pdf) (5/29/09)

May 5 and 6, 2008 (Joint Meeting with the Anesthetic and Life Support Drugs Advisory Committee)

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Waivers for Conflicts of Interest (htm)
  • Draft Agenda for May 5, 2008 Meeting (pdf)
  • Briefing Information for May 5, 2008 Meeting (html)
  • Draft Questions for May 5, 2008 Meeting (pdf)
  • Slides for May 5, 2008 Meeting (htm)
  • Slides for May 6, 2008 Meeting (htm)
  • Minutes for May 5, 2008 Meeting (pdf)
  • Minutes for May 6, 2008 Meeting (pdf)
  • Transcript for May 5, 2008 Meeting: Index (pdf), Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)
  • Transcript for May 6, 2008 Meeting: Index (pdf), Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)

February 1, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Amendment Notice [TXT] [PDF] [PRE-PUB]
  • Waivers for Conflicts of Interest (htm)
  • Draft Agenda (pdf)
  • Final Agenda (pdf)
  • Rosters: Attendee (pdf), Committee (pdf)
  • Final DSaRM Roster (pdf)
  • Briefing Information (htm)
  • Draft Questions (pdf)
  • Final Questions (pdf)
  • Slides (htm)
  • Final Minutes (pdf)
  • Transcript: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf), ERRATA (pdf)

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Endocrinologic and Metabolic Drugs Advisory Committee
Executive Secretary: Paul Tran, R.Ph., (HFD-21), (301) 827-7001

October 21, 2008 (Meeting ID: 2008-4389)

  • Notice of Meeting (htm)
  • Draft Agenda (pdf)
  • Roster: Committee (pdf), Meeting (pdf)
  • Briefing (htm)
  • Draft Questions (pdf)
  • Slides (htm)
  • Minutes (pdf)
  • Transcript: Index (pdf), Part1 (pdf), Part2 (pdf), Part3 (pdf)

July 1 and 2, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Waivers for Conflicts of Interest for July 1 and 2, 2008 Meeting (htm)
  • Agenda for July 1 and 2, 2008 Meeting (pdf)
  • Rosters for July 1 and 2, 2008 Meeting: Committee (pdf), Meeting (pdf)
  • Questions for July 1 and 2, 2008 Meeting (pdf)
  • Briefing Information for July 1 and 2, 2008 Meeting (htm)
  • Slides for July 1 & 2, 2008 Meeting (htm)
  • Transcript for July 1, 2008 Meeting: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf), Part5 (pdf)
  • Transcript for July 2, 2008 Meeting: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)
  • Minutes for July 1and 2, 2008 Meeting (pdf)

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Gastrointestinal Drugs Advisory Committee
Executive Secretary: Kristine Khuc, Pharm.D., (HFD-21), (301) 827-7001

January 23, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Waivers for Conflicts of Interest (htm)
  • Final Agenda (pdf)
  • Final Agenda (pdf)
  • Roster (pdf)
  • Briefing Information (html)
  • Final Questions for January 23, 2008 Meeting (pdf)
  • Slides (htm)
  • Minutes (pdf)
  • Transcript: Index (pdf), Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)

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Nonprescription Drugs Advisory Committee
Executive Secretary: LCDR Diem-Kieu Ngo, Pharm.D., (HFD-21), (301) 827-7001

October 29, 2008 (Joint Meeting with the Antiviral Drugs Advisory Committee)

  • Notice of Meeting (htm)
  • Waivers for Conflicts of Interest (htm)
  • Draft Agenda (pdf)
  • Rosters: AVAC Committee (pdf), NDAC Committee (pdf), Meeting Committee (pdf)
  • Briefing Information (htm)
  • Final Questions (pdf)
  • Questions (pdf)
  • Minutes (pdf)
  • Slides (htm)
  • Transcript: Index (pdf), Part 1 (pdf)

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Oncologic Drugs Advisory Committee
Executive Secretary: LT Nicole Vesely, Pharm.D., RPL (HFD-21), (301) 827-7001

December 16, 2008

  • Notice of Meeting
  • Waivers for Conflicts of Interest for December 16, 2008 Meeting (htm)
  • Final Agenda (pdf)
  • Draft Agenda (pdf)
  • Rosters: Committee (pdf), Draft Meeting (pdf), Final Meeting Roster (pdf)
  • Briefing Information (htm)
  • Final Questions (pdf)
  • Slides (htm)
  • Minutes (pdf)
  • Transcript: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)

May 30, 2008  

  • Waivers for Conflicts of Interest (html)
  • Final Agenda (pdf)
  • Draft Agenda (pdf)
  • Rosters for May 30, 2008 Meeting: Committee (pdf), Meeting (pdf)
  • Briefing Information for May 30, 2008 Meeting (htm)
  • Questions (pdf)
  • Written Statement (pdf)
  • Slides (htm)
  • Minutes (pdf)
  • Transcript: Part1 (pdf), Part2 (pdf)

March 12 and 13, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Amendment of Notice [TXT] [PDF] [PRE-PUB]
  • Draft Agenda for March 12, 2008 Meeting (pdf)
  • Draft Agenda for March 13, 2008 Meeting (pdf)
  • Rosters for March 12, 2008 Meeting: Meeting (pdf), Committee (pdf)
  • Rosters for March 13, 2008 Meeting: Meeting (pdf), Committee (pdf)
  • Briefing Information for March 12, 2008 Meeting (htm)
  • Briefing Information for March 13, 2008 Meeting (htm)
  • Final Agenda for March 12, 2008 Meeting (pdf)
  • Final Agenda for March 13, 2008 Meeting (pdf)
  • Final Questions for March 12, 2008 Meeting (pdf) (ppt)
  • Final Questions for March 13, 2008 Meeting (pdf)
  • Slides for March 12, 2008 Meeting (htm)
  • Slides for March 13, 2008 Meeting (htm)
  • Summary Minutes for March 12, 2008 Meeting (doc)
  • Summary Minutes for March 13, 2008 Meeting (doc)
  • Transcript for March 12, 2008: Part 1 (pdf), Part 2 (pdf), Part 3 (pdf)
  • Transcript for March 13, 2008: Part 1 (pdf), Part 2 (pdf), Part 3 (pdf)
  • Written Statements (pdf) (pdf)

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Pediatric Subcommittee

October 23, 2008

April 16, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Final Agenda (pdf)
  • Rosters: Meeting (pdf), Committee (pdf)
  • Briefing Information (htm)
  • Slides (htm)
  • Final Minutes (pdf)
  • Transcirpt: Part1 (pdf), Part2 (pdf), Part3 (pdf)

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Peripheral and Central Nervous System Drugs Advisory Committee
Executive Secretary: LCDR Diem-Kieu Ngo, Pharm.D., (HFD-21), 301 827-7001

October 23, 2008 (Meeting ID: 2008-4382)

  • Notice of Meeting (htm)
  • Final Agenda (pdf)
  • Draft Agenda (pdf)
  • Rosters: Committee (pdf), Meeting (Draft) (pdf), Final Meeting Roster (pdf)
  • Briefing Information (htm)
  • Final Questions (pdf)
  • Draft Questions (pdf)
  • Slides (htm)
  • Final Minutes (pdf)
  • Transcript (pdf)

August 6 and 7, 2008 (Mtg. ID: 2008-4376) !! MEETING POSTPONED !!

  • Notice of Meeting [TXT] [PDF]

July 10, 2008 Joint Meeting with Psychopharmacologic Drugs Advisory Committe

  • Notice of Meeting [TXT] [PDF]
  • No Waivers for Conflicts of Interest
This is the May 23, 2008 statistical review that describes the anti-epilepsy drugs suicidality metaanalysis conducted by the Agency. We are posting this document before the rest of the FDA background package because of the level of interest in this review. The rest of the background package will be posted when it is available.
  • Briefing Information (htm) (Updated 7/7/08)
  • Final Agenda (pdf)
  • Draft Agenda (pdf)
  • Final Meeting Roster (pdf)
  • Rosters: Committee-PCNS (pdf), Committee-PDAC (pdf), Meeting (pdf)
  • Final Questions (pdf)
  • Draft Questions (pdf)
  • Briefing Information (pdf)
  • Transcript (pdf)
  • Slides (htm)
  • Minutes (pdf)

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Pharmaceutical Science and Clinical Pharmacology Advisory Committee (Formerly Advisory Committee for Pharmaceutical Science)
Executive Secretary: LCDR Sohail Mosaddegh, Pharm.D., (HFD-21), (301) 827-7001

July 22 and 23, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Waivers for Conflicts of Interest for July 22 and 23, 2008 Meeting (html)
  • Final Agenda for July 22 and 23, 2008 Meeting (pdf)
  • Draft Agenda for July 22 and 23, 2008 Meeting (pdf)
    • Clarification of Agenda Item for July 23, 2008 Meeting (html)
  • Rosters for July 22 and 23, 2008 Meeting: Committee (pdf), Public (pdf)
  • Final Questions for July 22 and 23, 2008 Meeting (pdf)
  • Draft Questions for July 22 and 23, 2008 Meeting (pdf)
  • Briefing Information for July 22 and 23, 2008 Meeting (htm)
  • Slides for July 22, 2008 Meeting (htm)
  • Slides for July 23, 2008 Meeting (htm)
  • Transcript for July 22, 2008 Meeting: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)
  • Transcript for July 23, 2008 Meeting: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)
  • Final Minutes or July 22, 2008 Meeting (pdf)
  • Final Minutes or July 23, 2008 Meeting (pdf)

March 18 and 19, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Waivers for Conflicts of Interest (htm)
  • Final Agenda for March 18-19, 2008 Meeting (pdf)
  • Meeting Roster for March 18 & 19, 2008 (pdf)
  • Briefing Information or March 18 & 19, 2008 (htm)
  • Questions for March 18, 2008: Disease Model (ppt) (htm), Pediatric Design (ppt) (htm), PGx (ppt) (htm)
  • Questions for March 19, 2008 Meeting (ppt) (htm)
  • Slides for March 18, 2008 Meeting (htm)
  • Slides for March 19, 2008 Meeting (htm)
  • Final Minutes for March 18, 2008 Meeting (pdf)
  • Final Minutes for March 19, 2008 Meeting (pdf)
  • Transcript for March 18, 2008 Meeting: Index (pdf), Part1 (pdf)
  • Transcript for March 19, 2008 Meeting: Index (pdf), Part1 (pdf)

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Manufacturing Subcommittee

 

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Psychopharmacologic Drugs Advisory Committee
Executive Secretary: LT Yvette Waples, Pharm.D., HFD-21 (301) 827-7001

July 10, 2008 Joint Meeting with Peripheral and Central Nervous System Drugs Advisory Committee

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • No Waivers for Conflicts of Interest
This is the May 23, 2008 statistical review that describes the anti-epilepsy drugs suicidality metaanalysis conducted by the Agency. We are posting this document before the rest of the FDA background package because of the level of interest in this review. The rest of the background package will be posted when it is available.
  • Briefing Information (htm) (Updated 7/7/08)
  • Final Agenda (pdf)
  • Draft Agenda (pdf)
  • Final Meeting Roster (pdf)
  • Rosters: Committee-PCNS (pdf), Committee-PDAC (pdf), Meeting (pdf)
  • Final Questions (pdf)
  • Draft Questions (pdf)
  • Briefing Information (pdf)
  • Transcript (pdf)
  • Slides (htm)
  • Minutes (pdf)

February 6, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Amendment Notice [TXT] [PDF] [PRE-PUB]
  • Nature and Basis Statements of Conflict(s) of Interest for February 6, 2008 Meeting (htm)
  • Draft Agenda (pdf)
  • Final Agenda (pdf)
  • Rosters: Committee (pdf), Meeting (pdf)
  • Final Roster (pdf)
  • Briefing Information (htm)
  • Draft Questions (pdf)
  • Final Questions (pdf)
  • Slides (htm)
  • Transcript: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)
  • Minutes (pdf)

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Pulmonary-Allergy Drugs Advisory Committee
Executive Secretary: Kristine Khuc, Pharm.D., (HFD-21), (301) 827-7001

December 10 and 11, 2008 (Joint meeting with Drug Safety, Risk Management Advisory Committee and the Pediatric Adavisory Committee (Meeting ID: 2008- 4398)

  • Notice of Meeting
  • Waivers for Conflicts of Interest (htm)
  • Final Agenda (pdf)
  • Draft Agenda (pdf)
  • Meeting Roster (pdf)
  • Briefing Information (htm)
  • Final Questions (pdf)
  • Comments (pdf)
  • Slides for December 10, 2008 Meeting (htm)
  • Slides for December 11, 2008 Meeting (htm)
  • Final Minutes for December 10 and 11, 2008 (pdf)
  • Transcript for December 10, 2008 Meeting (pdf)
  • Transcript for December 11, 2008 Meeting (pdf)

February 20, 2008

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Reproductive Health Drugs Advisory Committee
Executive Secretary: Kalyani Bhatt, B.Sc., M.S., (HFD-21), (301) 827-7001

September 8, 2008

  • Notice of Meeting (html)
  • Agenda (pdf)
  • Draft Roster (pdf)
  • Briefing Information (htm)
  • Slides (htm)
  • Minutes (pdf)
  • Transcript (pdf)

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